Anxiety Clinical Trial
— AromatherapyOfficial title:
The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety in Primiparous Pregnant Women
NCT number | NCT05657431 |
Other study ID # | Cagan01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | November 30, 2021 |
Verified date | December 2022 |
Source | Eskisehir Osmangazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was conducted as a randomized controlled experimental study.To evaluate the effects of aromatherapy, one of the non-pharmacological pain methods, on labor pain and anxiety in the active phase in primiparous pregnant women. The main questions it aims to answer are: Is ylang ylang oil applied as an inhaler effective in reducing labor pain and anxiety? Is lemon oil applied as an inhaler effective in reducing labor pain and anxiety? Participants randomized according to the closed envelope method into the lemon oil group (n=15), ylang ylang oil group (n=15) and control group (n=15). In the active phase (cervical dilatation ≥5), a drop of essential oil was instilled onto square cotton balls to the intervention groups and renewed as one drop every hour until labor occurred. In the control group, 1 drop of saline was dripped onto square cotton balls. Visual pain scale (VAS) and state anxiety ınventory were applied to the intervention groups and control groups before the application. After the application, VAS and state anxiety ınventory were evaluated at 5-7 cm dilatation, and only with VAS at 8-10 cm dilatation. The trait anxiety ınventory was administered to the volunteers after birth.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Term pregnancy (37-41 weeks) - Pregnant women between the ages of 18-35 - had singleton pregnancy with cephalic presentation of the fetus - Not allergic to ylang ylang oil, flower/lemon or oil or anything - Absence of any pregnancy complications - No previous miscarriage, no abortion - Not having any diagnosed systemic disease - = 5 cm (cm) (active phase) cervical dilatation - Pregnant women who do not take any analgesia, anesthesia or anxiolytic drugs - Spontaneous onset of labor - Pregnant women who can speak and write Turkish well - Pregnant woman's consent to participate in the study. Exclusion Criteria: - Emergency cesarean section indication - Use of analgesic, anesthetic and anxiolytic drugs by the pregnant woman - The pregnant woman's desire to withdraw from the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Etlik Zübeyde Hanim Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Özlem Çagan |
Turkey,
Kaviani M, Maghbool S, Azima S, Tabaei MH. Comparison of the effect of aromatherapy with Jasminum officinale and Salvia officinale on pain severity and labor outcome in nulliparous women. Iran J Nurs Midwifery Res. 2014 Nov;19(6):666-72. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain score | Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain) | pre-intervention | |
Primary | pain score | Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain) | Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm | |
Primary | pain score | Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain) | Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range | |
Primary | anxiety level | Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20) | pre-intervention | |
Primary | anxiety level | Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20) | Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm | |
Primary | anxiety level | Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20) | postpartum 4-24 hours | |
Secondary | apgar score | Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." In the test, five things are used to check a baby's health. (0-10 point) | postnatal 5. minute | |
Secondary | apgar score | Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." In the test, five things are used to check a baby's health. (0-10 point) | postnatal 10. minute |
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